Those gold standard test results were compared with SD BIOLINE Duo test results. the evaluation during 2012C2013. Each site characterized sera using particle agglutination assay or hemagglutination assay and HIV enzyme immunoassay, Western blot, and/or HIV Rabbit Polyclonal to RBM5 antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo Nifurtimox test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CIs). Results. ?The sensitivity and specificity for the HIV antibody test component (= 2336) were estimated at 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the test component (= 2059), the sensitivity and specificity were estimated at 99.67% (95% CI, 98.82% and 99.96%) and 99.72% (95% CI, 99.29% and 99.92%), respectively. Conclusions. ?The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid assessments should be considered for improved HIV and syphilis screening coverage. antigen (17 kDa) in human serum. The recombinant HIV-1/2 antigen, recombinant antigen, colloid gold conjugate, the specimen sample and sample diluents move along the membrane chromatographically to the test region and form a visible line as the antigen-antibody-antigen gold particle complex forms [15]. Comparison Testing Each country had previously characterized samples that were used in this evaluation. For gold standard testing, each country used a combination of particle agglutination assay or hemagglutination assay for detection of syphilis contamination and enzyme immunoassay, Western blot, and rapid assessments for the detection Nifurtimox of HIV contamination. Nifurtimox The exact assessments and algorithms used for characterization of serum samples are displayed in Tables 1 and ?and22. Table 1. Country, Reference Assessments, and Algorithms for HIV Characterization in Sera Specimens Characterization in Sera Specimens hemagglutination assay. Data Analysis We calculated the sensitivity and specificity of test performance at each individual site using the exact binomial method to calculate 95% confidence intervals (CIs). Because we failed to find sufficient evidence against homogeneity of test performance between sites, we calculated a 95% CI using the exact binomial method around the combined data. We also considered a fixed effect and random effects logistic regression model to model the sensitivity and specificity in which the response variable was defined to be the dichotomous results of the screening test, a binary explanatory variable was defined by the gold standard, and testing site indicators were included in the model to Nifurtimox capture individual site effects [18, 19]. However, because there was near perfect test performance, the models failed to converge and yield sensible results. We were only able to fit the reduced simple logistic regression model around the combined data, and so we chose to report the exact binomial results only. Analyses were conducted using SAS, version 9.3 (Cary, NC). This analysis of deidentified laboratory data was decided to be exempt from human subject considerations. RESULTS Summarized results for each study site for HIV antibody test performance can be seen in Table ?Table3.3. Results for each study site for antibody test performance can be seen in Table ?Table4.4. In total, 2336 HIV-characterized specimens and 2059 syphilis-characterized specimens were used to evaluate this HIV/Syphilis Duo kit across the 6 countries. The combined sensitivity and specificity for testing HIV status was 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the detection of antibodies to Antibodies Using a Dual SD BIOLINE HIV/Syphilis Test in Previously Characterized Sera Samples in 6 Laboratory Sites antibody across 6 countries. Those findings of consistent high performance are similar to the high performance reported for single Nifurtimox point-of-care assessments for HIV and syphilis [20, 21]. Point-of-care assessments can result in accelerated linkage to treatment and care by decreasing the time to result and can be used in settings with limited laboratory access [22]. Dual rapid assessments with multiple analytes provide additional advantages by testing for multiple infections, and there is further efficiency in using a single device and a single specimen. Multiplex diagnostic.